Full Press Release Details
Media Contact - Glaucoma:
Vice President, Investor Relations & Corporate Affairs
Glaukos Announces FDA Approval of iDose
TR (travoprost intracameral implant)
Revolutionary, micro-invasive, injectable treatment
for the full range of glaucoma disease severity
iDose TR was designed to usher in a new era
of interventional glaucoma by enabling a proactive approach with a safe, effective, and durable therapy for patients in need
FDA approval based on robust Phase 3 clinical
program consisting of two pivotal studies that randomized 1,150 subjects across 89 clinical sites
Glaukos to host a conference call on December 14,
2023, at 8:30 a.m. ET / 5:30 a.m. PT
Aliso Viejo, CA -December 14, 2023
- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the
treatment of glaucoma, corneal disorders and retinal diseases, announced today the U.S. Food and Drug Administration (FDA) approved its
New Drug Application (NDA) for a single administration per eye of iDose TR (travoprost intracameral implant) 75
mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle
iDose TR is a first-of-its-kind, long-duration,
intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of
travoprost inside the eye for extended periods of time. iDose TR is intended to improve the standard of care by addressing the
ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
"The FDA approval of iDose TR represents
a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years
ago. Today's approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach
for patients in need," said Thomas Burns, Glaukos chairman and chief executive officer. "We believe iDose TR can be
a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular
hypertension. We are grateful to the clinical investigators and study participants in the clinical trials for their instrumental roles
in helping us reach this important advancement for glaucoma patient care. At Glaukos, we are relentlessly focused on delivering novel
therapies for chronic eye diseases and now iDose TR has the potential to redefine the standard of care for patients in the U.S.
affected by open-angle glaucoma and ocular hypertension."
"With the next generation of procedural
pharmaceutical solutions for glaucoma such as iDose TR, we now have a new tool that will confront the standard legacy practice
of relying on topical drops, which are known to cause uncomfortable side effects and present a myriad of challenges such as treatment
adherence, complex dosing regimens, and difficulty with self-administration," said John Berdahl, MD, clinician and researcher at
Vance Thompson Vision. "The clinical data suggest that iDose TR is not only effective with a favorable safety profile, but
it has potential to relieve patients from the burdens of prescription eye drops for an extended period of time. I look forward to adding
this novel therapy into my treatment toolbox for the benefit of my patients."
The FDA approval is based on results from two
prospective, randomized, multicenter, double-masked, Phase 3 pivotal trials (GC-010 and GC-012) designed to compare the safety and efficacy
of a single administration of one of two iDose TR models with different travoprost release rates (referred to as the fast- and
slow-release iDose TR models, respectively) to topical timolol ophthalmic solution, 0.5% BID (twice a day), in reducing IOP in
subjects with open-angle glaucoma or ocular hypertension. In total, the Phase 3 trials randomized 1,150 subjects across 89 clinical sites.
The FDA approval and Phase 3 data referenced below is for the slow-release iDose TR model, consistent with the company's
NDA submission and commercialization plans.
Both Phase 3 trials successfully achieved the
pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months.
IOP reductions from baseline over the first 3 months were 6.6-8.4 mmHg in the iDose TR arm, versus 6.5-7.7 mmHg in the timolol
control arm (mmHg range represents IOP reduction means across the six U.S. FDA pre-specified timepoints of 8 a.m. and 10 a.m. at
Day 10, Week 6 and Month 3). Based on these outcomes, the FDA concluded in the prescribing information that iDose TR demonstrated
non-inferiority to timolol ophthalmic solution in IOP reduction during the first 3 months. The FDA also noted that subsequently iDose
TR did not demonstrate non-inferiority over the next 9 months.
At 12 months, 81% of iDose TR subjects
were completely free of IOP-lowering topical medications across both trials. In both trials, iDose TR demonstrated excellent
tolerability and subject retention with 98% of iDose TR subjects continuing in the trial at 12 months, versus 95% of timolol
control subjects. In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of iDose TR patients were
increases in intraocular pressure, iritis, dry eye, and visual field defects, most of which were mild and transient in nature.
iDose TR is also supported by positive
results from a Phase 2b clinical trial, which were recently highlighted in a peer-reviewed publication in Drugs (link here).
The study authors concluded, "The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical
IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile."
Glaukos intends to commence initial commercial
launch activities for iDose TR in the latter part of the first quarter of 2024. Glaukos has established a wholesale acquisition
cost for iDose TR of $13,950, per dose (or implant).
Alongside the iDose TR approval announcement,
Glaukos is proud to introduce the iDose Your Dose Initiative. For every iDose TR sold, Glaukos pledges to make available an equal
number of iDose TR units for qualifying charitable donation requests in the U.S. and around the globe for recipients that satisfy
independent eligibility requirements.
For more information about iDose TR and
Full Prescribing Information, please visit www.iDoseTRhcp.com.
2023 and 2024 Revenue Guidance
The company reaffirms its 2023 net sales range
of $307 million to $310 million and introduces preliminary 2024 net sales guidance range of $350 million to $360 million.
Webcast & Conference Call
The company will host a conference call and simultaneous
webcast on December 14, 2023, at 8:30 a.m. ET (5:30 a.m. PT) to discuss the FDA approval of iDose TR. A link to
the webcast is available on the company's website at http://investors.glaukos.com. To participate in the conference
call, please dial 888-210-2212 (U.S.) or 646-960-0390 (international) and enter Conference ID 7935742. A replay of the webcast will be
archived on the company's website following completion of the call.
iDose TR (travoprost intracameral implant)
is a long duration prostaglandin analog approved for a single administration and indicated for the reduction of intraocular pressure (IOP)
in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Made from medical-grade titanium, iDose TR is implanted
through the trabecular meshwork and back wall of Schlemm's canal, directly into scleral tissue. Once implanted, 75 mcg of a novel, preservative-free,
proprietary formulation of travoprost continuously elutes into the anterior chamber via membrane-controlled diffusion, allowing for 24/7
release of medication.
Glaukos (www.glaukos.com) is an ophthalmic medical
technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal
disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma
treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct
and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of
these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders
and retinal diseases.
iDose TR Indication and Important Safety Information
INDICATIONS AND USAGE
iDose TR (travoprost intracameral implant) is
indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
Dosage and Administration
For ophthalmic intracameral administration. The
intracameral administration should be carried out under standard aseptic conditions.
iDose TR is contraindicated in patients with active
or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch's Dystrophy, corneal